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| Name | Class |
|---|---|
| Ontario Ministry of Health and Long Term Care | OTHER_GOV |
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In patients with an enlarged prostate (benign prostatic hyperplasia), is treatment using photoselective vaporization of the prostate (PVP 120 Watt) as effective and cost-effective as the standard treatment of transurethral resection of the prostate (TURP)? A higher-power (120W) laser system has recently been approved by Health Canada for the treatment of an enlarged prostate. This system, which uses laser energy to vaporize the prostate tissue, will be compared with the current standard treatment of transurethral resection of the prostate. This newer generation laser may offer more efficient removal of prostate tissue with fewer complications and may result in clinical and economic benefits compared to the standard treatment. However, there have been no studies comparing the 120W laser with the standard transurethral resection of the prostate. This study will provide currently unavailable information for clinicians and decision makers.
Following a review of treatments for benign prostatic hyperplasia (BPH) by the Medical Advisory Secretariat (MAS) of the Ontario Ministry of Health and Long-Term Care (MOHLTC), the Ontario Health Technology Advisory Committee (OHTAC) recommended that "a registry study be conducted to establish longer term effectiveness and complication rates for PVP given the likelihood of increasing diffusion of this technology". Since then, the Medical Devices Bureau of the Therapeutic Products Directorate, Health Canada, has licensed in April 30, 2007, a 120W-KTP laser system (Greenlight HPS (TM)) for sale in Canada. As several new 120W systems will be operating in Ontario in the coming months, there is an urgent need to evaluate the effectiveness, cost-effectiveness and durability of 120W PVP compared to conventional TURP in the treatment of patients with BPH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PVP | Experimental | Photoselective vaporization of the prostate. |
|
| TURP | Active Comparator | Transurethral resection of the prostate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GreenLight HPS (TM)laser system [Photoselective Vaporization of the prostate (PVP)] | Device | Photoselective vaporization of the prostate will be performed using the GreenLight HPS (TM)laser system (American Medical Systems), which is a high-power (120W) potassium titanyl phosphate (KTP) laser which was licensed by Health Canada in April 2007. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome is the change in International Prostatic Symptom Score (IPSS). | 6-months after surgery versus baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| International Prostatic Symptom Score (IPSS) | 1, 3, 12 and 24 months post procedure | |
| Peak or maximum urinary flow rate | 1, 3 and 6 months post surgery | |
| Post-void residual volume |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Eric Tarride, PhD | Program for Assessment of Technology in Health, St. Joseph's Healthcare/McMaster University | Study Chair |
| Gary McIsaac, MD | Trillium Health Centre | Principal Investigator |
| Edward Woods, MD | The Scarborough Hospital | Principal Investigator |
| Paul Whelan, MD | McMaster Institute of Urology at St. Joseph's Healthcare Hamilton | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster Institute of Urology at St. Joseph's Healthcare Hamilton | Hamilton | Ontario | L8N 4A6 | Canada | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24319513 | Result | Whelan JP, Bowen JM, Burke N, Woods EA, McIssac GP, Hopkins RB, O'Reilly DJ, Xie F, Sehatzadeh S, Levin L, Mathew SP, Patterson LL, Goeree R, Tarride JE. A prospective trial of GreenLight PVP (HPS120) versus transurethral resection of the prostate in the treatment of lower urinary tract symptoms in Ontario, Canada. Can Urol Assoc J. 2013 Sep-Oct;7(9-10):335-41. doi: 10.5489/cuaj.180. | |
| 24019857 |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D020728 | Transurethral Resection of Prostate |
| ID | Term |
|---|---|
| D011468 | Prostatectomy |
| D013521 | Urologic Surgical Procedures, Male |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
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| Transurethral resection of the prostate | Procedure | Transurethral resection of the prostate will be performed with a continuous flow resectoscope and unipolar cautery using a standard technique. |
|
|
| 1, 3, 6 month post procedure |
| Length of operation/procedure | During procedure |
| Frequency of blood transfusion | During procedure |
| Change in hemoglobin in recovery room | Following procedure |
| Postoperative serum electrolytes (sodium, creatinine) in recovery room | Following procedure |
| Duration of catheterization | 10 days after procedure |
| Occurrence of urethral stricture or bladder neck contracture requiring re-operation | up to 2 years after the procedure |
| Re-bleed rate requiring hospitalization | 1 month after procedure |
| Prostate-specific antigen (PSA) value | 3 months follow-up |
| Rate of re-operation | At 1, 6, 12 and 24 months following intervention |
| Rate of re-catheterization | 1, 6, 12 and 24 months following intervention |
| Rate of sexual dysfunction (SHIM) and/or retrograde ejaculation (specific question) | Pre-op, 1, 3, 6 months |
| Use of medications for the treatment of bladder outlet obstruction | 1, 3 and 6 months after intervention |
| Long-term durability of PVP and TURP (i.e. readmission, drug therapy) | At 12 and 24 months after intervention |
| IPSS quality of life score (Bother-score) | Pre-op, 1, 3, 6, 12 and 24 months |
| EQ-5D utility score | Pre-op, 1, 3, 6, 12 and 24 months |
| Resource utilization: hospital length of stay, OR time, pain medications, follow-up care (e.g. urologist visits, lab tests) | Pre-op, 1, 3, 6, 12 and 24 months |
| Productivity losses | Pre-op, 1, 3, 6, 12 and 24 months |
| Trillium Health Centre |
| Mississauga |
| Ontario |
| L5B 1B8 |
| Canada |
| The Scarborough Hospital | Scarborough Village | Ontario | M1P 2T7 | Canada |
| Result |
| Bowen JM, Whelan JP, Hopkins RB, Burke N, Woods EA, McIsaac GP, O'Reilly DJ, Xie F, Sehatzadeh S, Levin L, Mathew SP, Patterson LL, Goeree R, Tarride JE. Photoselective vaporization for the treatment of benign prostatic hyperplasia. Ont Health Technol Assess Ser. 2013 Aug 1;13(2):1-34. eCollection 2013. |
| D052801 |
| Male Urogenital Diseases |
| D013514 | Surgical Procedures, Operative |